Effects of a Proprietary Blend of Herbal Extract Supplement on Cellular Detoxification, Inflammation, and Cumulative Cognitive Index as Well as Gene Expression in Middle-Aged Adult Women

Phase 4

Completed

• Conditions: Anti Aging
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vitality product AM + Vitality product PM

• Registration Number: NCT01598272
• Lead Sponsor: Pharmanex

Brief Summary

Determine the effects of 8 week Investigational Supplement on cellular detoxification and gene expression profiles

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-15
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-10
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 95

Inclusion Criteria

1. Females aged 35-73 years
2. Signed informed consent
3. BMI between 23 and 35 kg/m2
4. A resting normotensive blood pressure is defined as a systolic blood pressure between 90-145 mmHg and a diastolic blood pressure of 50 90 mmHg
5. BioPhotonic scanner score below 30,000
6. Use of effective method of contraception by females of childbearing [potential and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study]. Acceptable methods of contraception include oral, injectable, or implantable contraceptives; intrauterine devices, diaphragm plus spermicide; or any double barrier method. Women who have had a hysterectomy or tubal ligation at least 6 months prior to Visit 1 or who have been post-menopausal for at least 1 year prior to Visit 1 are not considered to be of childbearing potential.
7. Ability to speak and understand English.
8. Willing to consume one high-fat high carbohydrate meal at the last visit consisting of 1 McDonald's egg Mcmuffin with cheese (no meat), 1 Sausage McMuffin with cheese (no egg), 2 hashbrowns, 1 12 oz Coke Cola or Sprite.
9. Willing to not exercise the morning of your last visit

Exclusion Criteria

1. Self-reported chronic condition that may affect subject safety (e.g., diabetes, cardiovascular disease) or significantly impact product effectiveness (e.g., chronic fatigue)
2. Pregnancy/suspected pregnancy, breastfeeding or planning to become pregnant during the course of the study.
3. Antihypertensive medication use.
4. Allergies to any ingredients contained in the Investigational Product.
5. Consumption of more than 600 mg of caffeine from all sources per day (equivalent to 24 oz. caffeinated coffee, 96 oz. of soda, 60 oz. of tea, 60 oz. energy drinks , or a combination thereof).
6. Consumption of herbal supplement known to affect energy levels (e.g., ginseng, cordyceps, licorice, Lycium, pomegranate, etc.).
7. Consumption of any of the supplements included in the formulas (Cordyceps sinensis, Panax Ginseng extract, pomegranate extract, red orange complex, grape seed extract or broccoli seed extract).
8. Known iron deficiency anemia.
9. Treatment for insomnia or depression within 30-days prior to the screening visit.
10. Recently started taking medication known to effect energy (e.g., thyroid medication). If taking medication (e.g., thyroid medication), must be stable for at least four months.
11. Tobacco (e.g. cigarettes, chewing tobacco, pipe, nicotine patches) use within 30-days prior to the screening visit.
12. Planned surgical procedure during the course of the study.
13. Currently participating in another study or have done so within 30 days prior to the screening visit or is likely to enroll in another clinical or nutritional study.
14. Any laboratory value that the investigator deems clinically significant.
15. Currently participating in a weight loss program or planning to go on a weight loss diet during the course of the study.
16. Allergies to egg or dairy products, Vegetarian or unwilling to consuming sausage.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Dietary Supplement: Placebo Placebo taken twice a day for 8 weeks
Vitality product AM + Vitality product PM	Vitality product AM + Vitality product PM	Dietary Supplement: Proprietary blend of ginseng, cordyceps, and pomegranate + proprietary blend of broccoli seed, red orange, and grape seed taken twice a day for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Determine effects of investigational supplement on gene expression profiles.	Day 0, Day 28, Day 56	Gene Expression Panel (microarray PBMCs), Inflammatory Panel, Oxidative stress Markers-including glutathione panel and F2 isoprostane, Anti-oxidant panel, and Lipid Panel

Secondary Outcome Measures

Name	Time	Method
Determine effects of investigational supplement on markers of inflammation	Day 0, Day 28, Day 56
Determine effects of investigational supplement on composite cognitive index	Day 0, Day 28, Day 56
Determine changes in scoring on HADS assessment (Hospital Anxiety & Depression Scale)	Day 0, Day 28, Day 56	Questionnaire: Hospital Anxiety and Depression Scale (HADS)
Determine changes in Quality of Life	Day 0, Day 28, Day 56	SF-36 (Quality of Life Assessment)
Determine changes in sleep patterns and quality	Day 0, Day 28, Day 56	Sleep measurement scale.
Determine changes to overall health	Day 0, Day 28, Day 56	Abbreviated Physical Exam
Establish a safety profile of investigational supplement	Day 0, Day 28, Day 56	Measure number of participants with adverse events. Fasted Safety Labs (chemistry, hematology, Coagulation)compared to baseline.
Determine changes to biological age scanning (Digital Pulse Wave Analyzer (DPA)	Day 0, Day 28, Day 56	Digital Pulse Wave Analyzer
Determine changes in Biophotonic Scanner Scores	Day 0, Day 28, Day 56	Measure antioxidants in the palm of the skin.
Determine changes in skin advanced glycation endproducts (AGE) levels	Day 0, Day 28, Day 56	AGE Reader

Trial Locations

Locations (1)

Aspen Clinical Research; 🇺🇸 Orem, Utah, United States